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Open, Classified

Duravent Silicone Ventilation Tube. Model Number: 240075.

FDA Recall Z-0707-2025 · Posted 2024-12-19

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeETD
Date Initiated2024-11-19
Product Quantity984 units

Reason for Recall

Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

Firm Action

Olympus notified consignees on 11/19/2024 via Courier, 2-day delivery. Consignees were instructed to examine inventory for affected devices, quarantine any affected devices on hand, arrange for return of those affected units and acknowledge receipt of the customer letter through the web portal.

Root Cause

Process control

Distribution Pattern

AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932166SILICONE TYMPANOSTOMY TUBESSmith & Nephew Richards, Inc. · 1993-07-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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